Medical Gas Compliance Alert

Medical Oxygen and Air Label Revisions

This GAWDA Medical Gas Compliance Alert is meant to inform GAWDA members that the medical oxygen and medical air labels are being revised according to the new medical gas regulations and new OSHA and GHS requirements.

Here are the primary revisions:

Medical Oxygen Changes

• The “Rx only” statement has been changed to “Rx required”
• No Smoking/No Vaping text and pictograms are to appear on the label
• OSHA/GHS warning statements have been revised

Medical Air Changes

• The “emergency use” option has been removed from the label text

The changes are to be included in CGA C-7, Guide to Classification and Labeling of Compressed Gases. The next CGA C-7 revision will not be completed in time for medical gas companies to change their labels before the FDA effective date, 18 December 2025. Therefore, CGA developed an interim publication to publish these changes, CGA PS-79, Updated Requirements for Medical Oxygen and Medical Air Cylinder Labels. CGA PS-79 is available on CGA’s website: CGANet.com.

Please consider working with your label supplier to get the new versions of these labels for your operations.

If you have questions about this, or other FDA issues, please contact GAWDA’s FDA and Medical Gas Consultant Tom Badstubner at [email protected] or 508-883-0927.